Unplanned
Intervention
Requested

Is the equipment in use?

Is use for GMP production?

Obtain verbal QA pre-approval for intervention / change

QA verbal pre-approval obtained and agrees to intervention / change

Issue Work order with Verbal QA approval documented

Execute Change Document Intervention / change on Work Order when assigned

QA requires deviation for intervention / change?

Work with QA and end user to initiate a Deviation

Is change to be made permanent?

Issue Change Control per Change Control Procedure

Complete

No intervention / change performed

Is change to be permanent?

Is it Like for Like?

Follow Planned Change Process

Issue Work order to perform work

Is change restored to validated state...?

Work with Quality to assess for Deviation

Obtain verbal QA pre-approval for intervention / change

Issue Work order with Verbal QA approval documented

Execute Change Document Intervention / change on Work Order when assigned

Work with QA and end user to initiate a Deviation

Is change to be made permanent?

Issue Change Control per Change Control Procedure

Is change to be permanent?

Issue Work order to perform work

Work with Quality to assess for Deviation